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OpenTrials
Completed

NCT Number: NCT00897611

Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma

RATIONALE: Studying levels of tumor DNA in the samples of blood from patients with cancer may help doctors find out whether the cancer has grown and how much.

PURPOSE: This laboratory study is comparing levels of tumor DNA with MRI and CT scan findings to measure cancer growth in patients with grade III or grade IV malignant glioma.

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Key information

About this study

OBJECTIVES:

  • Correlate changes in the level of serum tumor-specific DNA over time with changes in brain tumor size as measured by serial MRI or CT scans in patients with grade III-IV malignant gliomas.

OUTLINE: This is a multicenter study.

Blood samples are collected from patients at baseline and every 2 months thereafter. Tumor and nontumor plasma is extracted. Plasma samples are analyzed by polymerase chain reaction (PCR) to assess the p16_ink4a, p73, and O ^6-MGMT gene promoter methylation profile. Quantitative realtime PCR is performed on samples with tumor-specific DNA to determine the plasma concentrations of each methylated tumor-specific gene and the total plasma tumor-specific DNA concentration. Patients also undergo MRI or CT scans every 2 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant brain tumor
  • One of the following grade III or IV supratentorial gliomas:
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme
  • Newly diagnosed or recurrent disease
  • Planning to undergo anticancer therapy on a New Approaches to Brain Tumor Therapy (NABTT) Consortium clinical trial

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

DNA methylation analysis

Procedure

Other names: blood collection

polymerase chain reaction

Procedure

Other names: blood collection

Computed Tomography

Procedure

Other names: CT scan

Magnetic Resonance Imaging

Procedure

Other names: MRI scan

Primary outcomes

  1. Total plasma glioma-specific DNA concentration

    Time frame: every 2 months until death

  2. Tumor size

    Time frame: every 2 months until death

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)
  • North American Brain Tumor Consortium

Registry information

Official study title

Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings

Important dates

Study start
2005
Primary completion
2009
First posted
May 12, 2009
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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